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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The purpose of this submission is to expand the Indications for Use of the LOCATOR® Angled Abutment product line (K243272 & K233587) by adding compatibility of existing abutments with various new dental implant systems from Implant Direct and Biohorizons. Additionally, the submission expands the Indications for Use of the product line with a modified version of the predicate device shown to be compatible with the Implant Logistics Implant-One Series 300 and Series 400 Implant Systems. The LOCATOR Angled Abutment is designed and intended for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla, as cleared to be used with LOCATOR FIXED (K213391) and LOCATOR Attachment Systems (K072878).

The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated in various abutment heights, identical to the predicate device. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587 and K243272. The abutments will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration, identical to the predicate device.

The provided document is an FDA 510(k) clearance letter for the LOCATOR® Angled Abutment, K250721. This document primarily focuses on demonstrating substantial equivalence to a predicate device and expanding indications for use, rather than detailing a study that proves the device meets specific performance acceptance criteria for a new clinical application.

Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment (which are typical for AI/ML device clearances or those requiring extensive clinical performance data) is not present in this type of regulatory submission for a dental implant abutment.

However, based on the information provided, I can construct a table for the acceptance criteria and reported "performance" in the context of this 510(k) submission, which is primarily a demonstration of mechanical compatibility and safety rather than a clinical efficacy study.

Here's an interpretation based on the provided text:

Overview of Device Performance and Acceptance Criteria (as per the 510(k) Submission)

The LOCATOR® Angled Abutment (K250721) is a dental implant abutment. The "study" proving it meets acceptance criteria in this context is a series of non-clinical tests and engineering analyses demonstrating its compatibility with various dental implant systems and confirming its mechanical properties and biocompatibility are substantially equivalent to previously cleared devices. The acceptance criteria are implicitly met by showing conformance to established standards and similarity to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as "sample size" in the conventional sense for a clinical trial. For physical testing (fatigue, packaging), standard engineering test specimen numbers would have been used, but these are not detailed. For material and biocompatibility, existing data was leveraged. Functional compatibility was primarily through engineering analysis.
• Data Provenance: The data comes from in-vitro non-clinical testing and engineering analyses conducted by the manufacturer, Zest Anchors, LLC, or leveraged from previous submissions (K243272, K233587, K213391, K072878, K173701, K102822). The origin is the manufacturer's internal testing and regulatory submissions. The nature of these tests is "retrospective" in the sense that results from previous validated tests (e.g., K233587 for TiN coating, K072878 for biocompatibility) are being applied ("leveraged") to demonstrate equivalence for the current device, implying these tests were performed in the past.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. For this type of device (dental abutment) and submission (510(k) for expanded compatibility), "ground truth" is established through engineering specifications, material standards, and validated physical/mechanical testing protocols (e.g., ISO, ASTM). It does not involve human expert consensus on clinical images or patient outcomes.
• Qualifications of Experts: N/A, as the "ground truth" is based on objective, standardized physical and material properties, confirmed by engineering analysis.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring human adjudication of results. Engineering and laboratory tests have objective pass/fail criteria or conformance to standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. MRMC studies are typically for AI/ML devices where human readers interpret diagnostic images. This device is a physical dental implant component.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study Done? No. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's "performance" and "acceptance" is based on:
  • Engineering specifications and drawings: Ensuring physical compatibility (e.g., fit with implants).
  • International Standards: Conformance to mechanical testing standards (ISO 14801:2016 for fatigue), material standards (ASTM F136), and biocompatibility standards (ISO 10993 series).
  • Predicate device performance: Demonstrating that the subject device's design, materials, and performance characteristics are "identical" or "substantially equivalent" to previously cleared devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Established: Not applicable.

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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.

This document (K243272) is a 510(k) premarket notification for a dental device, the LOCATOR Angled Abutment. It is important to note that this document does not describe the performance of software or an AI device. Instead, it describes a mechanical dental implant component and its substantial equivalence to previously cleared predicates.

Therefore, many of the requested categories related to AI/software performance criteria, expert adjudication, MRMC studies, ground truth establishment for AI/ML, and training set information are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the acceptance criteria (in terms of performance testing for a mechanical device) and how the device meets them:

1. Table of Acceptance Criteria (for a mechanical device) and Reported Device Performance:

Study Details (for a mechanical device):

2. Sample sizes used for the test set and the data provenance:

   • Specific quantitative sample sizes for each mechanical test (e.g., number of abutments fatigued, number of coatings tested) are not detailed in this summary.
   • The data provenance is from non-clinical performance testing conducted by the manufacturer, Zest Anchors, LLC. This is typically internal laboratory testing.
   • The nature of the tests (fatigue, coating, packaging, functional fit) indicates this is prospective testing performed specifically to support this regulatory submission. Country of origin for data is not specified but is implicitly from the manufacturer's testing facilities (likely USA, given the submission location).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable as the "ground truth" for a mechanical device is established through objective engineering measurements and standardized performance tests (e.g., ISO, ASTM standards), not by human expert consensus on interpretations. The "experts" involved would be qualified engineers and technicians performing the tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers/experts in AI/medical image analysis. For mechanical device testing, the results are objectively measured and compared against predefined performance specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a mechanical dental abutment, not an AI or software product. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a mechanical abutment, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device's performance is based on established engineering principles, material science specifications, and adherence to international standards (e.g., ISO 14801, ASTM F1044, ASTM F1147, ISO 10993). Functional fit was verified against OEM implant specifications through direct testing.

8. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning model. There is no "training set."

9. How the ground truth for the training set was established:

   • Not applicable. As above, no training set exists for this type of device.

In summary, the provided document explicitly states that the submission aims to demonstrate substantial equivalence of the new LOCATOR Angled Abutment variations to existing predicate devices. This is achieved by showing that the new abutments share the same intended use, principles of operation, materials, manufacturing processes, and fundamental design, and they meet the same functional and performance characteristics through non-clinical testing. The "acceptance criteria" here refer to the successful completion and passing of these engineering and material performance tests against established standards.

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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment is designed to be used with LOCATOR FIXED and LOCATOR Attachment Systems for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. The LOCATOR Angled Abutment consists of various height abutment bodies with an integrated abutment screw. The attachment features are identical compared to LOCATOR Abutments of the LOCATOR High Retention Attachment System (LOCATOR FIXED), cleared in K213391. The LOCATOR Angled Abutment is compatible with Straumann BLX Implant System cleared in K173961. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment uses identical attachment features as the LOCATOR Abutments, but instead of the attachment features being aligned coaxially, the interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the device of K190040. The LOCATOR Angled Abutments and integrated abutment screw are manufactured from titanium (Ti-6Al-4V). The LOCATOR Angled Abutment body is titanium nitride (TiN) coated, identical to LOCATOR Abutments.

The provided FDA 510(k) summary for the "LOCATOR Angled Abutment" does not describe a study involving an AI/Machine Learning (ML) device or any specific performance metrics for such a device like sensitivity, specificity, or AUC, or a comparative effectiveness study involving human readers.

This submission is for a medical device (dental implant abutment) and focuses on demonstrating substantial equivalence to a predicate device through physical and mechanical testing, material compatibility, and intended use.

Therefore, I cannot provide a detailed answer to your request based on the provided text, as the information required (acceptance criteria for an AI/ML device, details of an AI/ML study, ground truth establishment, expert adjudication, MRMC studies, etc.) is not present.

In summary, the document does not contain the information needed to answer your questions regarding acceptance criteria and performance of an AI/ML device.

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The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system. The High Retention Attachment System is compatible with the following implants: (list of compatible implants and diameters provided in the document).

The High Retention Attachment System is a system that provides rigid connection of fixed, partial, and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It consists of abutments, attachment housings, inserts and seating and removal tools. The abutments are provided in various cuff heights with the implant and abutment connection specific to the Zest Anchors, LLC or OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated. The High Retention Attachment System is as provided with an abutment (LOCATOR Attachment) and the surgical instrumentation necessary to place the implant. The High Retention Attachment System is designed to accommodate a path of insertion diverqence of up to 20° per implant and no more than 40° of divergence between implants.

This document describes a 510(k) premarket notification for a dental device, the "High Retention Attachment System." It does not contain information about an AI/ML-driven medical device, hence no study details are provided to address the acceptance criteria for such a device. The content is primarily focused on demonstrating substantial equivalence to a predicate device through material, design, and intended use comparisons, rather than performance testing against specific acceptance criteria for an AI algorithm.

Therefore, I cannot provide the requested information from the provided text as it does not pertain to the performance and validation of an AI/ML medical device.

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The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The High Retention Attachment System is a system that provides rigid connection of fixed partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It is designed to accommodate a path of insertion on implants to accommodate a divergence of up to 20° per implant and no more than 40° of divergence between implants. The components are similar to the LOCATOR Implant Anchor Abutment, cleared in K072878; however, the retention and removal of the inserts is similar to that of the LOCATOR F-Tx Attachment System cleared in K151789.

The High Retention Attachment System consists of abutment housings, inserts, laboratory processing tools and seating and removal tools. Abutments, attachment housings and inserts are Class II subject devices (Product Code NHA) and laboratory processing tools and seating and removal tools are Class I accessories (Product Code NDP). The abutments are provided in various cuff heights with the implant/abutment connection specific to the OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.

This is a medical device, not an AI/ML device, so the requested information about acceptance criteria, study details, and training data for AI/ML models is not directly applicable.

Here's an analysis based on the provided document, addressing the principles of demonstrating substantial equivalence for a medical device:

The Zest Anchors, LLC "High Retention Attachment System" (K213391) is a Class II medical device (Endosseous Dental Implant Abutment, Product Code NHA). The FDA has determined it is substantially equivalent to legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the way one might for a specific performance metric of an AI/ML model (e.g., AUC > 0.9). Instead, substantial equivalence is demonstrated by comparing the new device's characteristics and performance to those of legally marketed predicate devices.

The table on page 7 outlines a comparison of the subject device with its primary predicate (K151789, LOCATOR F-Tx Attachment System) and two reference devices (K072878, LOCATOR Implant Anchor Abutment; K200827, LOCATOR R-Tx Attachment System).

Key Performance Demonstrations:

• Sterilization Validation and Biocompatibility Testing: The device undergoes these standard tests for medical devices. The materials and TiN coating are stated to have the "same specifications, processes, and are manufactured in the same facilities" as the predicate F-Tx Attachment System (K151789) and LOCATOR device (K072878). This implies the acceptance criteria for these tests were met as per established standards for similar devices.
• Mechanical Denture Retention Testing: This was a specifically conducted non-clinical test. The reported performance is that "The mechanical testing demonstrated that the retention force of the High Retention Attachment System was greater than retention force of the predicate device K151789." This indicates superior performance in this regard.
• Abutment-Implant Interface Compatibility: Verified through OEM signed abutment drawings, OEM implant drawings, or contractual agreements, and "engineering analysis." No specific performance testing was required due to this established compatibility and demonstrated equivalence to the LOCATOR R-Tx Attachment System (K200827).

2. Sample size used for the test set and the data provenance

For the mechanical denture retention testing, the document states tests were conducted, but it does not specify the sample size used for this testing. It is a non-clinical test, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the typical sense for patient data. It refers to laboratory/bench testing.

For sterilization validation and biocompatibility testing, these are typically conducted according to international standards (e.g., ISO standards) and involve specific sample sizes and protocols, but these details are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is not an AI/ML diagnostic tool that relies on expert interpretation to establish ground truth from patient data. The "ground truth" for this physical device is assessed through engineering specifications, material properties, and mechanical performance tests, not expert clinical interpretation of images or patient outcomes in the context of an AI study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the same reasons as point 3. There is no "test set" of clinical cases requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a dental implant attachment system, not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as there is no algorithm, nor is it an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained above, "ground truth" for this device is established through:

• Engineering specifications and drawings: For device design, dimensions, and implant compatibility.
• Material specifications and standards: Conformance to ASTM standards (e.g., ASTM F136 for titanium alloy).
• Laboratory performance testing: Such as mechanical denture retention force testing.
• Biocompatibility and sterilization standards: Demonstrating safety.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set.

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The LOCATOR® Overdenture Implant System is designed to retain overdentures in the mandible or maxilla. Immediate loading is indicated when good primary stability has been achieved and with appropriate occlusal loading.

The LOCATOR Overdenture Implant (LODI) was originally cleared under K120198. This submission is to add additional implant sizes to the LODI family that for distinction purposes, will hereinafter be called the Standard Ridge LOCATOR Overdenture Implant (LODI) System. The added implant sizes are listed in Table 1.0 below:

Table 1.0 Subiect Device Sizes

Identical to K120198, the subject LODI Standard Ridge System is designed to retain overdentures of partial dentures in the mandible or maxilla. The System includes a threaded and tapered endosseous dental implant that is made from the identical material, 6Al-4V ELI Titanium, and maintains its conformance to ASTM F136. The implant surface is roughened by Resorbable Blast Media (RBM) up to the abutment seating platform by the same manufacturing processes with the same manufacturing equipment as the existing LODI implant.

The provided text describes a 510(k) premarket notification for the "LOCATOR® Overdenture Implant System," specifically to add additional implant sizes to the existing system. The document focuses on demonstrating substantial equivalence to a predicate device (K120198) and a reference device (K192221) rather than presenting a study to prove acceptance criteria in the typical sense of a diagnostic or AI-driven medical device.

Therefore, many of the requested fields are not directly applicable to this type of submission which primarily relies on engineering and material testing to confirm equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This submission relies on engineering design principles, material science, and performance testing for mechanical, biological (biocompatibility, sterilization, cleanability, endotoxin), and shelf-life attributes, rather than a "test set" of clinical data. The acceptance criteria for manufacturing processes (e.g., sterilization, cleanability) are evaluated on representative devices or materials.
• Data Provenance: Not applicable in the context of clinical test data. The data provenance relates to internal manufacturing and testing records (e.g., ISO and USP standards for testing methods).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a clinical study involving expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a medical device (dental implant) and not an AI-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device (dental implant) and not an AI-driven algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable in the sense of clinical ground truth for a diagnostic device. The "ground truth" for this submission are the established engineering standards (e.g., ASTM F136 for material, ISO 11137-2 for sterilization, ISO 10993-1 for biocompatibility, USP for endotoxin) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established:

• Not applicable. This is not a machine learning or AI-driven device.

Summary of the Study/Approach:

The submission K203701 for the LOCATOR® Overdenture Implant System demonstrates substantial equivalence by showing that the new implant sizes are

• Made from the identical material (6Al-4V ELI Titanium conforming to ASTM F136).
• Have the same surface roughening process (Resorbable Blast Media, RBM).
• Maintain the same manufacturing processes and equipment.
• The Indications for Use remain within the scope of the predicate device (K120198).
• Performance testing (mechanical properties, corrosion, biocompatibility, sterilization, cleanability, fatigue, shelf-life, surface treatment, endotoxin) confirmed that adding new implant sizes either did not alter the existing safety and performance profile of the predicate device or, in cases of slight design changes (e.g., dual lead thread, blunted tip), did not create a new worst-case scenario. For instance, the larger cross-sectional area of the new implants was deemed to not introduce a new worst case for fatigue strength, and previous fatigue testing from K120198 was considered applicable. Similarly, the "new worst-case implant" (Standard Ridge LODI 4.9mm) was specifically tested for cleanability to meet acceptance criteria.

Note: "No clinical studies are provided as part of this 510(k) submission" is explicitly stated, reinforcing that this clearance relies on non-clinical (bench and material) testing and established equivalency principles.

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TurboTemp EZ is a is a self-cure crown-and-bridge composite indicated for the fabrication of long- and short-term provisional restorations including veneers, inlays/onlays, crowns, bridges and long-span bridges. TurboTemp EZ is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or a partial denture.

TurboTemp EZ is a provisional resin based material intended to be used for the fabrication of crowns, bridges, inlays, onlays, and veneers. The composite material is provided in a dual-barrel cartridge that when combined in the mixing tip, it is dispensed as a self-curing restorative material.

The provided text describes the regulatory clearance of a dental device, "TurboTemp EZ," and includes information relevant to its performance testing and comparison to predicate devices, rather than a study proving the device meets acceptance criteria in terms of algorithm performance for an AI/ML device.

Based on the content provided, here's an analysis structured according to your request, with the understanding that this is for a physical medical device, not an AI/ML algorithm:

1. A table of acceptance criteria and the reported device performance

For a physical dental material, acceptance criteria often relate to physical, chemical, and biological properties, usually benchmarked against industry standards or predicate devices.

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The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform

The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.

The provided text describes a 510(k) premarket notification for a medical device, the LOCATOR® F-Tx Attachment System. It focuses on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting a study design with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, many of the requested points regarding acceptance criteria, study types (MRMC, standalone), sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or cannot be extracted from this document, as it is not a performance study report for an AI/ML device.

This document outlines the device's intended use, design, materials, and provides a comparison to legally marketed predicate devices to establish substantial equivalence. The "Performance Data" section primarily details the non-clinical testing performed to meet various ISO standards related to sterilization, biocompatibility, and mechanical testing, which are typical for dental implant components.

Here's an attempt to address the request based only on the available information, noting where information is absent:

Acceptance Criteria and Device Performance for LOCATOR® F-Tx Attachment System

Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant non-clinical performance standards. The performance data presented focuses on material properties, sterilization, biocompatibility, and mechanical retention, rather than performance metrics for an AI/ML system.

1. Table of Acceptance Criteria and Reported Device Performance

• "Substantial equivalence in indications and design principles to legally marketed predicate devices." Comparing language: "The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments." |
  | - Similar Design Principles | - "LOCATOR F-Tx and Locator (K072878) are each provided with varving cuff heights. The abutment/implant interfaces of all LOCATOR F-Tx abutments are identical to those of the corresponding Locator (K072878) abutments." |
  | - Similar Materials | - Abutment: Ti-6Al-4V ELI (same as predicate).
• Abutment Coating: TiN (same as predicate), TiCN (same as reference predicate K150295).
• Prosthetic Retention Component: PEEK (predicate uses Nylon). This difference is noted but deemed acceptable. |
  | Material Biocompatibility (ISO 10993-1, -5, -12) | - "Characterization and biocompatibility testing of the TiCN coating,"
• "Biocompatibility testing of the PEEK Healing Caps."
• (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
  | Sterilization (ISO 17665-1, -2) | - "Sterilization testing."
• (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
  | Mechanical Performance (Specifically Retention Strength) | - "The mechanical testing demonstrated the retention strength of the LOCATOR F-Tx Attachment System when using the High Retention Balls was statistically greater than the tensile force created when masticating worst case sticky food (p

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The SATURNO™ Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla. The SODI is used to restore masticatory function for the patient and may be suitable for immediate function if sufficient primary stability of the implant is achieved at the time of placement.

The SATURNO™ Overdenture Implant (SODI) System is a one-piece, self-tapping, threaded, root-form . dental implant with the abutment portion being either straight or angled for overdenture prosthetic attachment. SODI implants are provided in three diameters (2.0, 2.4 and 2.9 mm), three lengths (10, 12. and 14 mm) and two cuff heights (2.0 and 4.0 mm). Each size SODI implant has a 1.8 mm attachment ball and is available with a straight or 200 angled abutment section.

The SATURNO™ Overdenture Implant System is a dental implant system designed to retain overdentures or partial dentures. The submission indicates that no clinical testing data was submitted, referenced, or relied upon to demonstrate substantial equivalence. Therefore, there is no study that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission states that "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing demonstrated the subject device to be equivalent to or stronger than the tested predicate device."

This means the acceptance criteria are not clinical performance measures but rather engineering and mechanical testing standards.

Here's a breakdown based on the provided text, while acknowledging the absence of a clinical study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Since no clinical study was conducted or relied upon for this premarket notification, there is no "test set" in the context of patient data. The "test set" refers to the dental implants and materials used in the engineering and mechanical testing. The sample sizes for these non-clinical tests are not specified in the provided text. The data provenance is described as "Non-clinical testing data submitted."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable as there was no clinical test set requiring expert ground truth establishment for patient outcomes. The acceptance criteria were based on established engineering standards (like ISO 14801) and comparisons to predicate devices, which would involve engineering expertise during the testing and analysis.

4. Adjudication Method for the Test Set

This is not applicable as there was no clinical test set requiring adjuducation of patient outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical data were not submitted in this premarket notification." The focus was on demonstrating substantial equivalence through non-clinical testing.

6. Standalone Performance Study

No standalone performance study (in the context of an algorithm or human-in-the-loop performance) was done. The device is a physical medical device (dental implant system), and its performance was assessed through engineering and mechanical testing, not through an algorithmic or human-in-the-loop evaluation.

7. Type of Ground Truth Used

The "ground truth" for demonstrating equivalence was based on:

• Established engineering standards: Specifically, ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
• Comparison to predicate devices: The physical dimensions, characteristics, materials, and operating principles of the SATURNO™ Overdenture Implant System were considered "equivalent" to previously marketed and cleared devices.

8. Sample Size for the Training Set

This is not applicable. There was no "training set" in the context of machine learning. The "training" for this device involved its design and manufacturing process to meet the established engineering and safety standards.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. Since there was no "training set" in the machine learning sense, there's no ground truth establishment for it. The "ground truth" for the device's design and manufacturing revolves around adherence to established quality systems, materials science principles, and relevant engineering standards, as demonstrated through the non-clinical tests.

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Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.

Chairside Attachment Processing Material is a composite that is used to secure denture cap attachments into dentures. These attachments are commonly used in conjunction with dental implants to assist in affixing dentures to the wearer. Chairside Attachment Processing Material can be used chairside (to pick up the attachments from the mouth of the patient) or in a laboratory setting (using a model of the patient's mouth).

The provided text describes a medical device (Chairside® Attachment Processing Material) seeking 510(k) clearance, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than establishing novel acceptance criteria and proving they are met through a dedicated study.

Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets specific performance metric acceptance criteria in the way typically seen for a new or significantly modified device where extensive clinical or standalone performance studies against predefined targets are conducted.

Instead, the submission demonstrates "substantial equivalence" to predicate devices based on:

1. Similarities in Usage and Design: The device has the same intended use, operating principle, basic design, similar materials, and packaging as predicate devices.
2. Performance Testing against Standards: Non-clinical data, specifically performance testing, was conducted following established ISO standards (ISO 20795-1 and ISO 4049) relevant to dental materials. This testing aims to show that the device performs similarly to or within the acceptable range for such materials, as represented by the predicates.

Here's a breakdown of the requested information based on the provided text, with explicit notes where the requested information is absent:

1. A table of acceptance criteria and the reported device performance

• Note: The document only states that these tests were performed and that the data "demonstrates substantial equivalence." It does not provide the specific numerical acceptance criteria for each test or the exact performance results of the Chairside® Attachment Processing Material against those criteria. This level of detail is often found in the full 510(k) submission, not typically in the summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document mentions "non-clinical data" and "performance testing" based on ISO standards. These standards prescribe sample sizes, but the specific number of samples tested for each property (flexural strength, water sorption, etc.) is not detailed in this summary.
• Data Provenance: Not specified. The tests were performed to demonstrate substantial equivalence, likely at Zest Anchors, LLC or a contracted lab. The country of origin and whether it was retrospective or prospective is not applicable as these were lab-based performance tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This submission is for a material (dental composite) and relies on objective, standardized physical/chemical property testing (e.g., flexural strength, water sorption) rather than expert interpretation of data or images to establish a "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. See point 3. This device does not involve human interpretation or subjective judgment on a test set that would require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a dental material, not an AI-assisted diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a dental material. There is no algorithm or AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Objective Material Property Standards: The "ground truth" or reference for evaluating this device's performance relies on established physical and chemical property standards from ISO (e.g., ISO 20795-1, ISO 4049) for comparable dental materials. The performance metrics themselves (e.g., specific flexural strength values) are the "truth" against which the device is measured to demonstrate substantial equivalence to predicates.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a material, not a machine learning algorithm.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set" for this type of device.

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